Actively Recruiting
Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
Led by University Hospital, Lille · Updated on 2026-05-18
900
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) affects 2-4% of people in western countries and significantly reduces quality of life. This condition involves a specific immune response leading to inflammation and nasal polyps. Researchers are evaluating biologic treatments that target these immune pathways to better manage CRSwNP, aiming to improve patient quality of life and tailor treatments using biomarkers in this prospective study. The study monitors patients with severe CRSwNP who receive biologic drugs such as dupilumab, mepolizumab, or benralizumab given by subcutaneous injection every two weeks or every month, depending on marketing approvals. Some patients already treated since August 2021 will have their past clinical and biological data collected retrospectively. The study plans a follow-up period of 5 years to assess treatment impact and tolerance. Participants will provide patient-reported outcomes regularly, with evaluations at treatment start, 3 months, 6 months, and every 6 months up to 5 years. Researchers will track quality of life changes, symptom progression, time to any surgical procedures, and blood markers including eosinophil count and total IgE levels. This detailed monitoring aims to understand how biologic therapies affect CRSwNP over the long term and ensure patient safety and compliance.
CONDITIONS
Brief Title
BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old requiring biologic treatment for CRSwNP as approved
- Patients already treated since August 2021 with available clinical and biological data
You will not qualify if you...
- Oral corticosteroid use within the previous month
- Biologic treatment with anti-IgE, anti-IL-5/IL-5R, anti-IL-4/IL-13R, or other biotherapies for inflammatory diseases in the 6 months before treatment start, except for severe asthma or CRSwNP
- Hypersensitivity to humanized antibodies
- Documented COVID-19 infection in the last 3 months with ongoing smell disorders
- Pregnant or breastfeeding women
- Patients without social coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive biologic treatments for Chronic Rhinosinusitis with Nasal Polyps according to marketing approval, administered subcutaneously every month or every two weeks.
Visits at Month 0, Month 3, Month 6, and every 6 months thereafter until 5 years
Trial Site Locations
Total: 2 locations
1
CHU de Lille
Lille, France
Active, Not Recruiting
2
chu de Lille
Lille, France
Actively Recruiting
Research Team
G
Geoffrey Mortuaire, MD, pHD
G
Geoffrey Mortuaire
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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